Cardiac Contractility Modulation (CCM) for Heart Failure

Heart failure (HF) is a chronic syndrome in which the heart muscle is unable to pump enough blood to meet the body’s needs. Lifestyle modification, guideline-directed medical therapy (GDMT), and implanted devices, including cardiac resynchronization therapy (CRT) are all methods used to treat this condition. Despite advancements in treatment options, mortality among patients with HF is high. CCM is designed to treat select HF patients who continue to have persistent symptoms despite GDMT and are ineligible for CRT. CCM devices deliver electrical stimulation to the heart muscle to increase the strength of the heart's contractions. This technology may improve symptoms, quality of life, functional capacity, and exercise tolerance.

CMS received a complete, formal request to provide coverage for CCM for Heart Failure. This is a Transitional Coverage for Emerging Technologies (TCET) pilot that tested the processes and concepts of TCET.

This NCA will focus on the clinical indications for use of CCM among Medicare beneficiaries. This NCA will analyze clinical evidence for patient characteristics or comorbidities that make patients more or less likely to benefit from the device, as well as evidence for improved health outcomes specifically in Medicare beneficiaries. Other outcomes of interest will include decreased mortality, decreased frequency of HF exacerbations requiring emergency room or hospital admission, improved function, and quality of life. The scope of this NCA is limited to CCM for Heart Failure.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of CCM for Heart Failure. We are also interested in health disparities and equity aspects that should be considered in the review.

January 10, 2025